Method and apparatus for reducing femoral fractures

ABSTRACT

An improved method and apparatus for reducing a hip fracture utilizing a minimally invasive procedure which does not require incision of the quadriceps. A femoral implant in accordance with the present invention achieves intramedullary fixation as well as fixation into the femoral head to allow for the compression needed for a femoral fracture to heal. To position the femoral implant of the present invention, an incision is made along the greater trochanter. Because the greater trochanter is not circumferentially covered with muscles, the incision can be made and the wound developed through the skin and fascia to expose the greater trochanter, without incising muscle, including, e.g., the quadriceps. After exposing the greater trochanter, novel instruments of the present invention are utilized to prepare a cavity in the femur extending from the greater trochanter into the femoral head and further extending from the greater trochanter into the intramedullary canal of the femur. After preparation of the femoral cavity, a femoral implant in accordance with the present invention is inserted into the aforementioned cavity in the femur. The femoral implant is thereafter secured in the femur, with portions of the implant extending into and being secured within the femoral head and portions of the implant extending into and being secured within the femoral shaft.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of co-pending U.S. patent applicationSer. No. 10/155,683, filed May 23, 2002, which is a continuation-in-partof U.S. patent application Ser. No. 09/520,351, filed Mar. 7, 2000, nowU.S. Pat. No. 6,447,514, the disclosures of which are hereby expresslyincorporated herein by reference.

BACKGROUND

1. Field of the Disclosure

The present invention relates to a method and apparatus for treating hipfractures, and, more particularly, to a method and apparatus forreducing femoral fractures utilizing a minimally invasive procedure.

2. Description of the Related Art

Current procedures utilized to reduce hip fractures generally utilize aside plate/hip screw combination, i.e., a bone plate affixed to alateral aspect of the femur and having a hip screw operably connectedthereto, with the hip screw extending into the femoral head. To properlyimplant a side plate hip screw, a surgeon must dissect an amount ofmuscle to expose the femur and operably attach the bone plate and hipscrew. Typically, the side plate hip screw requires an incision of about10-12 cm through the quadriceps to expose the femur. While this approachprovides surgeons with an excellent view of the bone surface, theunderlying damage to soft tissue, including muscle, e.g., the quadricepscan lengthen a patient's rehabilitation time after surgery.

SUMMARY

The present invention provides an improved method and apparatus forreducing a hip fracture utilizing a minimally invasive procedure whichdoes not require dissection of the quadriceps. A femoral implant inaccordance with the present invention achieves intramedullary fixationas well as fixation into the femoral head to allow for the compressionneeded for a femoral fracture to heal. The femoral implant of thepresent invention allows for sliding compression of the femoralfracture. To operably position the femoral implant of the presentinvention, an incision aligned with the greater trochanter is made andthe wound is developed to expose the greater trochanter. The size of thewound developed on the surface is substantially constant throughout thedepth of the wound. In one exemplary embodiment of the presentinvention, the incision through which the femur is prepared and theimplant is inserted measures about 2.5 centimeters (3.9 inches). Becausethe greater trochanter is not circumferentially covered with muscle, theincision can be made and the wound developed through the skin and fasciato expose the greater trochanter, without incising muscle, including,e.g., the quadriceps. After exposing the greater trochanter, novelinstruments of the present invention are utilized to prepare a cavity inthe femur extending from the greater trochanter into the femoral headand further extending from the greater trochanter into theintramedullary canal of the femur. After preparation of the femoralcavity, a femoral implant in accordance with the present invention isinserted into the aforementioned cavity in the femur. The femoralimplant is thereafter secured in the femur, with portions of the implantextending into and being secured within the femoral head and portionsthereof extending into and being secured within the femoral shaft. Toallow for sliding compression, the portion of the implant extending intothe femoral head is slidable relative to the portion of the implantextending into the femoral shaft.

The femoral implant of the present invention includes a sealed baghaving a fill tube positioned therein to provide access to the baginterior so that the implant bag can be filled with material, e.g., bonecement after implantation of the femoral implant within the cavityformed in the femur. The femoral implant of the present inventionfurther includes a lag screw tube placed within the bag of the femoralimplant. The bag of the femoral implant is tightly secured to theexterior of the lag screw tube to prevent material injected into the bagfrom escaping the bag at any point at which the bag contacts the lagscrew tube. The lag screw tube is hollow and accommodates a lag screw orother fixation device to be advanced into and secured to the femoralhead. The sealed bag of the femoral implant of the present invention canbe, e.g., formed of various films and fabrics. In one exemplaryembodiment the bag of the femoral implant of the present invention isformed from an acrylic material. Because bone cement is an acrylic, ifthe implant bag is formed of an acrylic, the bag and the bone cementwill achieve an intimate chemical bond. In a further embodiment of thepresent invention, the bag structure of the implant of the presentcomprises a nested bag structure in which an inner bag is filled with ahigh strength material relative to an outer bag in which the inner bagis placed. The outer bag of this form of the present invention is formedfrom and filled with a more bioresorbable material relative to thematerial of construction and fill material of the inner bag.

The femoral implant of the present invention is inserted through anaccess aperture formed in the greater trochanter and placed within thefemoral cavity described hereinabove. The lag screw or other fixationdevice is thereafter advanced through the lag screw tube and into thecavity formed in the femoral head. The lag screw or other fixationdevice is then secured to the femoral head. The fill tube is thereafterutilized to fill the femoral implant with, e.g., bone cement to fill thefemoral cavity and provide intramedullary fixation and stabilization ofthe lag screw. In an alternative embodiment of the present invention,bone cement is utilized in lieu of lag screw threads to secure a lagscrew shaft of an implant of the present invention.

Several different guides and reamers may be utilized in accordance withthe present invention to ream the femoral cavity described hereinabove.These novel guides and reamers will be described in detail in thedetailed description portion of this document. Generally, the guides andreamers of the present invention are designed to allow for formation ofa femoral cavity from the greater trochanter across the femoral neck andinto the femoral head as well as from the greater trochanter into theintramedullary canal, with the femoral cavity having exposed accessthereto only over the greater trochanter. The method and apparatus ofthe current invention advantageously allow for the treatment of afemoral hip fracture in a minimally invasive procedure, which hastenspatient recovery.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of this invention,and the manner of attaining them, will become more apparent and theinvention itself will be better understood by reference to the followingdescription of embodiments of the invention taken in conjunction withthe accompanying drawings, wherein:

FIG. 1 is a partial perspective view of a patient, with an incision madealong the greater trochanter to allow for implantation of a femoralimplant of the present invention;

FIG. 2 is a partial perspective view illustrating insertion of a guideplate in accordance with the present invention;

FIG. 3 is a partial perspective view illustrating a guide tube/retractorin accordance with the present invention inserted through the incisionaligned with the greater trochanter and engaged with the guide plate;

FIG. 4 is an elevational view illustrating the use of an alignmentdevice of the present invention to properly select the appropriate guidetube/retractor of the present invention;

FIG. 5 is an elevational view illustrating the alignment guide of FIG. 4properly aligned from the greater trochanter along the femoral neck tothe femoral head;

FIG. 6 is a sectional view of a femur illustrating a plunge reamerutilized to begin making the femoral cavity of the present invention;

FIG. 7 is a sectional view illustrating the use of a swivel reamer inaccordance with the present invention to further form the femoralcavity;

FIG. 8 is a sectional view illustrating further use of the swivel reamerdepicted in FIG. 7 to form the femoral cavity;

FIG. 9 is a sectional view illustrating the use of a curved femoral headreamer to extend the femoral cavity into the femoral head;

FIG. 10 is a sectional view illustrating the use of a curved femoralreamer to extend the femoral cavity into the intramedullary canal of thefemur;

FIG. 11 is a sectional view illustrating a femoral cavity formed inaccordance with the present invention;

FIG. 12 is a sectional view illustrating insertion of a femoral implantof the present invention into the femoral cavity illustrated in FIG. 11;

FIG. 13 is a sectional view illustrating extension of the bag of thefemoral implant into the intramedullary canal;

FIG. 14 is a sectional view illustrating extension of a lag screwthrough the lag screw tube and into the femoral head, as well as a pumpand source of bag fill, e.g., bone cement, utilized to fill the bag ofthe femoral implant of the present invention;

FIG. 15 is a perspective view of a guide plate in accordance with thepresent invention;

FIGS. 16, 17, and 18 are, respectively, top, side, and bottomelevational views thereof;

FIG. 19 is a sectional view of an insertion member of the presentinvention with the guide plate illustrated in FIGS. 15-18 affixedthereto;

FIG. 20 is a perspective view of an insertion member which is utilizedto operably position a guide plate, e.g., the guide plate illustrated inFIGS. 15-18 atop the greater trochanter as illustrated in FIG. 2;

FIG. 21 is a partial elevational view illustrating deactuation of thelatch utilized to temporarily fix the guide plate to the insertionmember;

FIG. 22 is a side elevational view of the insertion member illustrated,e.g., in FIG. 20;

FIG. 23 is a perspective view of a guide tube/retractor of the presentinvention;

FIG. 24 is a radial elevational view thereof;

FIG. 25 is a further radial elevational view thereof, rotatedapproximately 90 degrees with respect to the radial elevational view ofFIG. 24;

FIG. 26 is a proximal axial view thereof;

FIG. 27 is a distal axial view thereof;

FIG. 28 is a radial elevational view of an angled guide tube/retractorof the present invention;

FIG. 29 is a perspective view of an alignment device of the presentinvention;

FIG. 30 is an elevational view thereof;

FIG. 31 is a perspective view of a plunge reamer of the presentinvention;

FIG. 32 is a distal axial view thereof;

FIG. 33 is a partial sectional, elevational view thereof;

FIG. 34 is a perspective view of a swivel reamer of the presentinvention;

FIG. 35 is a proximal axial elevational view thereof;

FIG. 36 is a sectional view taken along line 36-36 of FIG. 38;

FIG. 37 is a distal axial elevational view thereof;

FIG. 38 is a partial sectional, elevational view of the swivel reamer ofthe present invention;

FIG. 39 is a perspective view of a curved femoral head reamer of thepresent invention;

FIG. 40 is a sectional view thereof;

FIG. 41 is an elevational view of a femoral implant of the presentinvention;

FIG. 42 is an exploded view of a lag screw of the present invention;

FIG. 43 is a sectional view of the femoral implant of the presentinvention taken along line 43-43 of FIG. 41;

FIG. 44 is a perspective view of an alternative embodiment alignmentdevice of the present invention;

FIG. 45 is an elevational view thereof;

FIG. 46 is a perspective view of a combination reamer in accordance withthe present invention;

FIG. 47 is a sectional view thereof illustrating actuation of theswivel/plunge reaming selector into the plunge reaming position;

FIG. 48 is a sectional view thereof with the swivel/plunge reamingselector moved into position for swivel reaming;

FIG. 49 is a partial sectional view of the combination reamer of thepresent invention;

FIG. 50 is a perspective view of an alternative embodiment guide platein accordance with the present invention;

FIGS. 51-54 are top, end, side, and bottom elevational views thereof,respectively;

FIG. 55 is a sectional view thereof taken along line 55-55 of FIG. 53;

FIG. 56 is a perspective view of an alternative embodiment guidetube/retractor of the present invention;

FIG. 57 is a radial elevational view thereof;

FIG. 58 is a radial elevational view of an alternative embodiment angledguide tube/retractor of the present invention;

FIG. 59 is a distal axial elevational view of the guide tube/retractorillustrated in FIG. 57;

FIG. 60 is a partial sectional view of the guide tube/retractorillustrated in FIG. 57 taken along line 60-60 thereof;

FIG. 61 is a perspective view of a fixation screw in accordance with analternative embodiment of the present invention;

FIG. 62 is a radial elevational view thereof;

FIG. 63 is a distal axial view thereof;

FIG. 64 is a proximal axial view thereof;

FIG. 65 is a perspective view of a second alternative embodiment guideplate in accordance with the present invention;

FIG. 66 is a top elevational view thereof;

FIG. 67 is a sectional view thereof taken along line 67-67 of FIG. 66;

FIG. 68 is a bottom elevational view thereof;

FIG. 69 is a perspective view of a second alternative embodiment guidetube/retractor in accordance with the present invention;

FIG. 70 is a radial elevational view thereof;

FIG. 71 is an exploded view of a flexible reamer guide in accordancewith the present invention;

FIG. 72 is a sectional view thereof;

FIG. 73 is a sectional view illustrating the flexible reamer guide ofFIGS. 71 and 72 operably positioned within a patient's femur to guide aflexible reamer into the femoral head;

FIG. 74 is a sectional view illustrating a flexible reamer positionedover a flexible reamer guide wire for reaming into the femoral head;

FIG. 75 is a perspective view of a flexible reamer in accordance withthe present invention;

FIG. 76 is a sectional view thereof;

FIG. 77 is an exploded view of a flexible reamer guide wire bender inaccordance with the present invention;

FIG. 78 is an elevational view thereof;

FIG. 79 is a sectional view thereof;

FIG. 80 is an axial view of the distal end of a fixation screw placementinstrument in accordance with the present invention;

FIG. 81 is a perspective view of the fixation screw placement instrumentpartially illustrated in FIG. 80;

FIG. 82 is a perspective view of a straight reamer utilized to preparethe greater trochanter to receive the fixation screw illustrated in FIG.61-64;

FIG. 83 is a perspective view of an alternative embodiment insertionmember for inserting a guide plate of the present invention;

FIG. 84 is a partial sectional view thereof illustrating the releasebars thereof actuated to effect release of the guide plate from lockingengagement with the insertion member;

FIG. 85 is a partial sectional view illustrating the release bars of theinsertion member illustrated in FIG. 83 positioned whereby the guideplate can be temporarily fixed to the insertion member;

FIG. 86 is an elevational view of the insertion member illustrated inFIG. 83;

FIG. 87 is a perspective view of a spring lock release instrument inaccordance with the present invention;

FIG. 88 is a partial sectional view of the distal end thereof,illustrating the release pins in an unactuated position;

FIG. 89 is a sectional view of the spring lock release instrument ofFIG. 87 actuated to force release pins 346 to protrude therefrom;

FIG. 90 is an elevational view of an alternative embodiment femoralimplant of the present invention;

FIG. 91 is a sectional view of an alternative embodiment lag screw ofthe present invention, illustrating insertion of an actuating device foractuating the lag screw head; and

FIG. 92 is a partial sectional view of a further alternative embodimentlag screw of the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. Although the drawings representembodiments of the present invention, the drawings are not necessarilyto scale and certain features may be exaggerated to better illustrateand explain the present invention. The exemplifications set out hereinillustrate embodiments of the invention, and such exemplifications arenot to be construed as limiting the scope of the invention in anymanner.

DETAILED DESCRIPTION

Implant 260 illustrated in FIG. 41 is utilized to reduce a femoralfracture utilizing a method of implantation which does not requireincision of the quadriceps. As illustrated in FIG. 1, incision 106 isaligned with greater trochanter 110, with femur 108 being prepared toreceive implant 260 through incision 106. As described above, greatertrochanter 110 is not covered with muscle and therefore, incision 106can be developed to expose greater trochanter 110 without requiring theincision of muscle. As illustrated in FIGS. 6-10, various novel reamersof the present invention are utilized to form femoral cavity 224 (FIG.11). As illustrated in FIG. 12, implant 260 (further illustrated inFIGS. 41-43) is inserted into femoral cavity 224 via an access formedthrough greater trochanter 110. As illustrated in FIG. 13, lag screw 264is advanced into femoral head 114 until lag screw threads 282 firmlyengage femoral head 114 and lag screw 264 has achieved the positionillustrated in FIG. 14. Bag 270 is thereafter filled with material,e.g., bone cement to fill femoral cavity 224 and provide intramedullaryfixation of implant 260 and stabilization of lag screw 264. In this way,a femoral fracture including, e.g., an intertrochanteric fracture can bereduced. Generally, this document will refer to a femoral fracture and,specifically, to an intertrochanteric fracture. However, the method andapparatus of the present invention is adaptable to various bonefractures including, e.g., supracondylar fractures of the femur.

FIG. 1 generally illustrates patient 100 including torso 102, and legs104. FIG. 1 further illustrates the general bone structures comprisingthe hip joint including, pubis 122, anterior superior iliac spine 118,ilium 116, acetabulum 120, and femur 108. As illustrated in FIG. 1,femur 108 includes, e.g., greater trochanter 110, femoral neck 112, andfemoral head 114. As described above, incision 106 is aligned withgreater trochanter 110. Because greater trochanter 110 is not coveredwith muscle, incision 106 can be made and the wound developed throughthe skin and fascia to expose greater trochanter 110 without incisingmuscle, including, e.g., the quadriceps.

After making incision 106 as illustrated in FIG. 1, cannulated insertionmember 124 is utilized to insert guide plate 126 through incision 106 tobe placed atop and secured to greater trochanter 110 as illustrated,e.g., in FIG. 2. After guide plate 126 traverses incision 106 and isplaced atop greater trochanter 110, stabilization nail 144 is positionedthrough elongate aperture 132 of insertion member 124 and impactioninstrument 148 (FIG. 2) is utilized to strike impaction surface 146 todrive stabilization nail 144 into femur 108 to provide initial stabilityto guide plate 126 prior to utilizing screws 128 (FIG. 1) to fix guideplate 126 to greater trochanter 110. In one exemplary embodiment, thesurgeon implanting guide plate 126 will utilize a fluoroscope to verifyproper placement of guide plate 126 atop greater trochanter 110. Inalternative embodiments, the surgeon implanting guide plate 126 willutilize tactile feedback either alone or in conjunction with afluoroscope image to determine proper placement of guide plate 126 atopgreater trochanter 110. After guide plate 126 is properly positionedatop greater trochanter 110, screws 128 are driven through correspondingscrew apertures 286 (FIG. 15) in guide plate 126 and into femur 108 tosecure guide plate 126 to femur 108. Screw apertures 286 are, in anexemplary embodiment, formed in guide plate 126 to allow for obliqueinsertion of screws 128 relative to guide plate 126.

Insertion member 124 is illustrated in detail in FIGS. 19-22. Asillustrated, insertion member 124 includes elongate aperture 132accommodating stabilization nail 144 as described hereinabove. Insertionmember 124 includes tubular latch connector 140 positioned about thedistal end thereof. Intermediate the main body of insertion member 124and tubular latch connector 140 is positioned spring 136. Spring 136acts against spring stop 150 to bias tubular latch connector into theposition illustrated in FIG. 22. Release member 134 is connected totubular latch connector 140 and is operable to facilitate movement oftubular latch connector 140 against the biasing force of spring 136 intothe position illustrated in FIG. 21. Insertion member 124 includesdistal end 142 for engaging guide plate 126. Distal end 142 includesbosses 152 extending therefrom.

Guide plate 126 is temporarily affixed to insertion member 124 asdescribed below. Bosses 152 enter attachment channels 290 of guide plate126 (see, e.g., FIGS. 15 and 17). Concurrently latch 138, connected totubular latch connector 140, acts against the proximal surface of guideplate 126 to force tubular latch connector 140 against the biasing forceof spring 136 and into the position illustrated in FIG. 21. Distal end142 of insertion member 124 is then rotated until bosses 152 arepositioned under lips 291 formed by attachment channels 290 and latch138 can be positioned within one of attachment channels 290 and returnedto its naturally biased position as illustrated in FIGS. 19 and 22. Whenguide plate 126 is attached to insertion member 124, one of bosses 152and latch 138 abut opposing radial extremes of one attachment channel290 to prevent relative rotation of guide plate 126 and insertion number124. Moreover, when guide plate 126 is attached to insertion member 124,bosses 152 cooperate with lips 291 formed by attachment channels 290 toprevent relative axial displacement of guide plate 126 and insertionmember 124. In this way, guide plate 126 is secured to insertion member124 to facilitate positioning guide plate 126 atop greater trochanter110 as described hereinabove.

After guide plate 126 is secured to greater trochanter 110, releasemember 134 may be actuated to position latch 138 in the positionillustrated in FIG. 21 to allow for rotation of distal end 142 ofinsertion member 124. When latch 138 is positioned as illustrated inFIG. 21, it is no longer contained within attachment channel 290 andtherefore allows relative rotation between guide plate 126 and insertionmember 124. Distal end 142 of insertion member 124 is rotated toreposition bosses 152 out of axial alignment with lips 291 for removalfrom attachment channels 290. Insertion member 124 is thereafter removedfrom engagement with guide plate 126 and removed through incision 106.

After securement of guide plate 126 atop greater trochanter 110, guidetube/retractor 154 is inserted through incision 106 and releasably fixedto guide plate 126 as illustrated in FIG. 3. Guide tube/retractor 154 isillustrated in detail in FIGS. 23-27, and guide plate 126 is illustratedin detail in FIGS. 15-18. With reference to FIGS. 23-27 and 15-18, thecooperating apparatus of guide tube/retractor 154 and guide plate 126allowing for selective locking of guide tube/retractor 154 to guideplate 126 will now be described. Fixation of guide tube/retractor 154 toguide plate 126 is effected by first positioning attachment protrusions302 of straight guide tube/retractor 154 into attachment channels 290 ofguide plate 126. Guide tube/retractor 154 is then rotated clockwise toposition the radially extending portion of attachment protrusions 302under lips 291 formed by attachment channels 290 of guide plate 126.Once rotated into this position, spring biased locking pin 294 of guidetube/retractor 154 is positioned within lock detent 292 of guide plate126 to prevent relative rotation of guide plate 126 and guidetube/retractor 154 and lock guide tube/retractor 154 to guide plate 126.

As illustrated in FIGS. 23 and 24, spring biased locking pin 294 extendssubstantially axially along guide tube/retractor 154 and is operablyconnected to actuation member 300 to provide for manual actuation oflocking pin 294. Spring 298 is operatively associated with spring biasedlocking pin 294 and the interior of the cylindrical wall forming guidetube/retractor 154 to bias locking pin 294 into the position illustratedin FIG. 24. When distal shoulder 303 of guide tube/retractor 154 isinitially positioned atop the proximal end of guide plate 126, withattachment protrusions 302 entering attachment channels 290, locking pin294 is moved against the biasing force of spring 298 until guidetube/retractor 154 is rotated as described hereinabove to align lockingpin 294 with detent 292 and lock guide tube/retractor 154 to guide plate126.

While the engagement of a guide tube/retractor of the present inventionwith guide plate 126 has been described with respect to straight guidetube/retractor 154, angled guide tube/retractor 296 is locked to guideplate 126 in the same manner utilizing the same structure as describedabove with respect to straight guide tube/retractor 154. The sharedcomponents of straight guide tube/retractor 154 and angled guidetube/retractor 296 are denoted with primed reference numerals. Themechanism for locking a guide tube/retractor of the present invention toguide plate 126 allows for locking of a guide tube/retractor to guideplate 126 in one of two positions separated by 180 degrees. This allowsfor angled guide tube/retractor 296 to provide for realignment in twodirections as will be further described hereinbelow.

Guide tube/retractor 154 serves the dual purpose of maintaining anaccess from incision 106 to greater trochanter 110 and guiding variousinstruments utilized to prepare femoral cavity 224 (FIG. 11). Generally,either a straight or an angled guide tube/retractor will be utilized.FIGS. 24 and 28 respectively illustrate straight guide tube/retractor154 and angled guide tube/retractor 296. As illustrated, e.g., in FIG.28, angled guide tube/retractor 296 includes distal end 299 andretractor body 301. Longitudinal axis 297 of distal end 299 of angledguide tube/retractor 296 forms an angle Ø of about 10° with longitudinalaxis 303 of retractor body 301. In this way, angled guide tube/retractor296 allows for a 10° realignment with respect to straight guidetube/retractor 154. The surgeon will choose either straight guidetube/retractor 154 or angled guide tube/retractor 296 based upon thegeometry of femur 108 into which implant 260 (FIG. 41) will be placed.In accordance with the present invention, an alignment device isprovided to facilitate choice of straight guide tube/retractor 154 orangled guide tube/retractor 296 as well as the orientation of angledguide tube/retractor 296 as further described hereinbelow.

FIGS. 4 and 5 illustrate use of alignment device 156 to choose eitherstraight guide tube/retractor 154 or angled guide tube/retractor 296.Alignment device 156 is illustrated in detail in FIGS. 29 and 30 andincludes extension 166 connected to transverse bar 168, with alignmentarm 174 slidably attached thereto. As illustrated in FIG. 29, extension166 is connected to insertion member 160 at a distal end thereof.Insertion member 160 is sized for insertion into either straight guidetube/retractor 154 or angled guide tube/retractor 296 as illustrated inFIGS. 4 and 5.

As illustrated in FIGS. 29 and 30, insertion portion 160 of alignmentdevice 156 includes distal end 158 connected via connecting rods 184 topositioning cylinder 164. Positioning cylinder 164 includes a pair ofopposing bosses 162, only one of which is depicted in FIGS. 29 and 30.Distal end 158 and positioning cylinder 164 have external geometriessized to cooperate with the hollow interior of the guide tube/retractorsof the present invention to provide a stationary base for alignmentdevice 156, as illustrated in FIGS. 4 and 5. Insertion portion 160 ofalignment device 156 as illustrated in FIGS. 29 and 30 comprises merelyone exemplary design for an insertion portion of alignment device 156operable to stabilize alignment device 156 with the guidetube/retractors of the present invention. Generally, insertion portion160 will include a portion thereof having an exterior geometry sized tocooperate with the interior of the guide tube/retractors of the presentinvention to provide a stationary base for alignment device 156. In analternative embodiment, the insertion portion of alignment device 156depicted in FIGS. 29 and 30 comprises a solid insertion member having aconsistent cross sectional area along its length. In this embodiment,the exterior of the solid insertion member will cooperate with theinterior of the guide tube/retractors of the present invention toprovide a stable connection of alignment device 156 with a guidetube/retractor in accordance with the present invention.

Alignment device 156 includes transverse bar 168 fixed to extension 166via screw 170. Positioning cylinder 164 and extension 166 provide astable base for transverse bar 168. As illustrated in FIGS. 29 and 30,alignment arm 174 is slidably connected to transverse bar 168 viaslidable attachment member 176. Slidable attachment member 176 includesattachment block 178 having a cutout therein accommodating transversebar 168. Top plate 180 is mounted atop attachment block 178, with setscrew 172 threaded therein. Set screw 172 traverses top plate 180 toselectively engage transverse bar 168 and lock alignment arm 174 inposition along transverse bar 168.

As illustrated in FIGS. 4 and 5, alignment device 156 is utilized tofacilitate selection of the appropriate guide tube/retractor. FIG. 5illustrates alignment device 156 operably positioned within straightguide tube/retractor 154, which is locked to guide plate 126. In use,bosses 162 on positioning cylinder 164 are positioned within attachmentchannels 290 of guide plate 156 and positioning cylinder 164 is rotateduntil bosses 162 contact the terminal ends of channels 290 and arepositioned under lips 291. After positioning alignment device 156 withinguide tube/retractor 154, slidable attachment member 176 may be adjustedto accommodate the physiological characteristics of the patient andplace alignment arm 174 adjacent the patient's skin. Alignment arm 174of alignment device 156 includes a curved distal end having a curvaturebased on statistical data which follows a path from the central portionof greater trochanter 110, along the central axis of femoral neck 112,to the central region of femoral head 114. FIG. 5 illustrates anarrangement with the distal end of alignment arm 174 following theaforementioned path on femur 108. In the environment illustrated in FIG.5, straight guide tube/retractor 154 is the appropriate guidetube/retractor to be utilized to effect the method of the presentinvention. In some cases, the distal end of alignment arm 174 will notcoincide with the aforementioned path on the femur in question due to,e.g., the specific geometry of the bone in question. In this case,angled guide tube/retractor 296 may be utilized in an attempt to providethe appropriate alignment with the femur in question.

FIG. 4 illustrates alignment device 156 utilized with angled guidetube/retractor 296 on femur 108. As described above, femur 108,illustrated, e.g., in FIGS. 4 and 5 has a geometry accommodating the useof straight guide tube/retractor 154. With this in mind, FIG. 4 isuseful in illustrating a situation in which the distal end of alignmentarm 174 does not follow a path from the central portion of greatertrochanter 110, along the central axis of femoral neck 112 to thecentral region of femoral head 114 and, therefore, use of the attachedguide tube/retractor, i.e., angled guide tube/retractor 296 iscontraindicated. Comparison of the distal end of alignment arm 174 tothe aforementioned path from the central portion of the greatertrochanter, along the central axis of the femoral neck to the centralportion of the femoral head will be effected during surgery with the useof a fluoroscope.

Generally, straight guide tube/retractor 154 will first be locked toguide plate 126, and alignment device 156 will be operably positionedtherein. A fluoroscope will then be utilized to compare the distal endof alignment arm 174 with the path from the central portion of thegreater trochanter, along the central axis of the femoral neck to thecentral portion of the femoral head. If the distal end of alignment arm174 does not follow the aforementioned path from the central portion ofthe greater trochanter to the central portion of the femoral head, thenalignment device 156 and straight guide tube/retractor 154 will beremoved and angled guide tube retractor 296 will be locked to guideplate 126. The angle Ø of about 10° formed between longitudinal axis 297of distal end 299 of angled guide tube/retractor 296 and longitudinalaxis 303 of retractor body 301 allows for an approximately 10 degreerealignment on either side of the longitudinal axis of straight guidetube/retractor 154 in a plane substantially containing the central axisof femur 108. The inventors of the current invention have found thatthis 10 degree realignment in either direction typically accounts forthe various bone geometries encountered. However, the inventors of thepresent invention further contemplate provision of additional angledguide tubes/retractors having an angle Ø as described hereinabove ofother than 10 degrees. For example, Ø could measure 5°, 10°, or 15° toprovide for increased versatility in performing the method of reducing afemoral fracture in accordance with the present invention.

Once the appropriate guide tube/retractor is chosen and attached toguide plate 126, cavity 224 (FIG. 11) can be formed in femur 108. Asillustrated in FIG. 6, straight reamer 186 is first positioned withinguide tube/retractor 154 and utilized to create access 101 in greatertrochanter 110. In one exemplary embodiment, access 101 has a 1.9centimeter (0.75 inch) diameter. After creating access 101 in greatertrochanter 110, straight reamer 186 is removed from guide tube/retractor154 and replaced with swivel reamer 202 as illustrated, e.g., in FIG. 7.As illustrated in FIG. 7, swivel reamer 202 is rotatable about pivot 216and, in the configuration illustrated in FIG. 7, allows for theextension of femoral cavity 224 toward femoral head 114. After femoralcavity 224 is extended as illustrated in FIG. 7, swivel reamer 202 isrepositioned to allow for extension of femoral cavity 224 toward theshaft of femur 108 as illustrated in FIG. 8. Swivel reamer 202 is thenremoved in favor of curved femoral head reamer 226. As illustrated inFIG. 9, curved femoral head reamer 226 is advanced through access 101into femoral head 114, thus expanding femoral cavity 224 into femoralhead 114. Curved femoral head reamer 226 is thereafter removed fromguide tube/retractor 154 and replaced with curved femoral shaft reamer244, as illustrated in FIG. 10. Curved femoral shaft reamer 244 ispositioned through access 101 into the intramedullary canal of femur108, as illustrated in FIG. 7, to extend femoral cavity 224 into thefemoral shaft. The reaming process illustrated in FIGS. 6-10 producesfemoral cavity 224 as illustrated, e.g., in FIG. 11.

Straight reamer 186 is illustrated in detail in FIGS. 31-33. Asillustrated in FIGS. 31-33, straight reamer 186 includes straight reamerguide tube 188 surrounding straight reamer shaft 192. Straight reamerguide tube 188 is positioned intermediate straight reamer head 190 andflange 194 and is operable to move along reamer shaft 192 therebetween.Straight reamer guide tube 188 as an exterior geometry cooperating withthe internal geometry of straight guide tube/retractor 154 and/or angledguide tube/retractor 296 to provide a solid base for reaming femur 108as illustrated in FIG. 6. Straight reamer 186 further includes proximalend 198 adapted to be received in chuck 200 (FIG. 6) of any of the wellknown rotation devices utilized to impart rotational motion to variousmedical instruments including, e.g., reamers. Straight reamer guide tube188 includes opposing bosses 196 protruding from the exterior surfacethereof. Bosses 196 are engagable in boss channels 304 formed in theproximal end of the guide tube/retractors of the present invention (see,e.g., FIGS. 23, 24, and 28).

In use, straight reamer guide tube 188 is positioned within a guidetube/retractor of the present invention, with bosses 196 entering bosschannels 304 formed in a proximal end thereof. Guide tube 188 is thenrotated until bosses 196 are positioned beneath the lip formed by theproximal end of straight guide tube/retractor of the present inventioncovering the radially extending portions of boss channels 304. In thisposition, guide tube 188 cannot readily be axially displaced withrespect to the guide tube/retractor into which it is inserted. Proximalend 198 of straight reamer 186 is actuated to provide rotationalmovement of reamer head 190 to form access 101 in femur 108. Afterachieving a predetermined reamer depth, flange 194 contacts the proximalend of guide tube 188 to limit axial displacement of reamer head 190. Inone exemplary embodiment, straight reamer 186 is configured to provide areaming depth of 1.9 centimeters (0.75 inches) into femur 108.

Swivel reamer 202 is illustrated in detail in FIGS. 34-38. Asillustrated in FIGS. 34-38, swivel reamer 202 includes swivel reamerguide tube 204 having opposing bosses 212 protruding therefrom. Swivelreamer guide tube 204 includes cutout 210 operable to allow reamer shaft208 to pivot about swivel reamer pivot 216 as further describedhereinbelow and as illustrated in FIG. 38. Similar to straight reamer186, swivel reamer 202 includes proximal end 214 operable to connectswivel reamer 202 to chuck 200 (FIG. 7). Bosses 212 are utilized toconnect swivel reamer 202 to a guide tube/retractor of the presentinvention in the same manner as bosses 196 of straight reamer 186.

As illustrated in FIG. 36, swivel reamer pivot 216 is pivotallyconnected to swivel reamer guide tube 204 via pivot pins 218. Asillustrated in FIG. 38, swivel reamer pivot 216 is positioned aboutreamer shaft 218 and abuts enlarged portion 222 of swivel reamer shaft208 and flange 220 on opposing axial ends thereof to prevent axialdisplacement of swivel reamer head 206. As illustrated in FIGS. 7 and 8and described hereinabove, the orientation of swivel reamer 202 ischanged 180 degrees to accommodate swivel reaming toward femoral head114 as illustrated in FIG. 7 as well as swivel reaming toward thefemoral shaft as illustrated in FIG. 8. As illustrated, e.g., in FIGS.24 and 25, the guide tube/retractor of the present invention includesopposing cut-outs 305 to accommodate swivel reaming toward femoral head114 as illustrated in FIG. 7 as well as swivel reaming toward thefemoral shaft as illustrated in FIG. 8, without repositioning the guidetube/retractor.

Curved femoral head reamer 226 is illustrated in detail in FIGS. 39 and40. As illustrated in FIGS. 39 and 40, curved femoral head reamer 226includes guide tube 228 having bosses 236 protruding therefrom. Bosses236 are utilized to position curved femoral head reamer 226 within guidetube/retractor of the present invention as described above with respectto straight reamer 186 and swivel reamer 202. Curved femoral head reamer226 includes curved reamer shaft 232 having reamer head 230 operablyconnected to a distal end thereof. Proximal end 234 of curved reamershaft 232 is operable to connect curved reamer 226 to chuck 200 of anactuation device as illustrated in FIG. 9. As illustrated in FIG. 40,curved reamer shaft 232 comprises a hollow shaft formed by outer tube242. Flexible driveshaft 240 is positioned within outer tube 242 andallows for transmission of rotary motion from proximal end 234 of curvedreamer 226 to reamer head 230 to effect reaming into femoral head 114 asillustrated in FIG. 9. Guide tube 228 of curved femoral head reamer 226includes curved guide channel 238 for guiding movement of outer tube 242of reamer shaft 232 as reamer head 230 is advanced into femoral head 114as illustrated in FIG. 9. Curved femoral shaft reamer 242 is notillustrated in detail for the sake of brevity. Curved femoral shaftreamer 242 has an identical structure to curved femoral head reamer 226.In an exemplary embodiment of the present invention, the head of femoralshaft reamer 242 is larger than the head of curved femoral head reamer226. Similarly, the head of curved femoral head reamer 226 may be largerthan the head of curved femoral shaft reamer 242. Moreover, the radiusof curvature of the reamer shafts may differ between curved femoral headreamer 226 and curved femoral shaft reamer 242. In all cases, a tubularreamer shaft and flexible driveshaft is utilized.

After formation of femoral cavity 224, any remaining guidetube/retractor as well as guide plate 126 is removed and implant 260 ispositioned through access 101 to be implanted in femoral cavity 224.During implantation of implant 260, retractors are utilized to provideaccess from incision 106 to access 101. As illustrated in FIG. 12, bag270 (FIG. 41) is manipulated into a relatively small package positionedabout lag screw tube 266 to be positioned through access 101. In oneexemplary embodiment, bag 270 is accordion folded. As furtherillustrated in FIG. 12, fill tube 262 and reinforcement/expansion bar268 of femoral implant 260 are positioned adjacent lag screw tube 266for positioning implant 260 through access 101 and into femoral cavity224. When femoral implant 260 is fully inserted through access 101, lagscrew thread 282 abuts the proximal end of femoral head arm 256 ofimplant cavity 224 as illustrated, e.g., in FIG. 13. In this position,fill tube 262 and reinforcement/expansion bar 268 can be manipulatedinto the operable position illustrated in FIG. 14. In this position, bag270 extends into femoral shaft arm 258 of implant cavity 224. Afterimplant 260 is positioned as illustrated in FIG. 13, a flexible drivedevice is utilized to advance lag screw 264 into femoral head 114 untilreaching the terminal position illustrated in FIG. 14. With lag screw264 firmly implanted in femoral head 114, pump P is utilized to convey abag fill material for filling bag 270 from source of bag fill 284through fill tube 262. In one exemplary embodiment, source of bag fill284 comprises a source of bone cement. Fill tube 264 is formed toprovide for retrograde filling of bag 270. As bag 270 is filled with,e.g., bone cement, it expands to fill femoral cavity 224, including,femoral shaft arm 258 thereof. Once bag 270 is filled, the bone cementinjected therein cures and provides intramedullary fixation of femoralimplant 260. As indicated above, in a further embodiment of the presentinvention, the bag structure of the implant of the present comprises anested bag structure in which an inner bag is filled with a highstrength material relative to an outer bag in which the inner bag isplaced. The outer bag of this form of the present invention is formedfrom and filled with a more bioresorbable material relative to thematerial of construction and fill material of the inner bag.

Implant 260 is illustrated in detail in FIG. 41. As illustrated in FIG.41, bag 270 is secured to lag screw tube 266 to prevent materialinserted into bag 270 from escaping between the contact points formedbetween bag 270 and lag screw tube 266. As further illustrated in FIG.41, reinforcement/expansion bar 268 is positioned to facilitatedeployment of implant 260 into femoral shaft arm 258 of femoral cavity224 as described hereinabove. Reinforcement/expansion bar 268 will notbe utilized in every embodiment of the present invention. As illustratedin FIG. 43, reinforcement/expansion bar 268 also functions to laterallyspread bag 270 to facilitate placement of bone cement therein. Asillustrated in FIG. 41, fill tube 262 is positioned within bag 270, withbag 270 securely affixed to a proximal end thereof.

FIG. 90 illustrates alternative embodiment femoral implant 260′. Femoralimplant 260′ is generally identical to femoral implant 260 illustratedin FIG. 41 except for the provision of external fasteners 279 utilizedto securely affix bag 270′ to lag screw tube 266. Although notillustrated in FIG. 90, it is contemplated that femoral implant 260′will include a fill tube 262′ for filling bag 270 with bone cement.

Alternative embodiments of the lag screw of the present invention areillustrated in FIGS. 42, 91, and 92. As illustrated in FIG. 42, lagscrew 264 generally comprises curved lag screw shaft 274 rotatablyconnected to lag screw head 272. In the embodiment illustrated in FIG.42, lag screw shaft 274 includes distal male threads 276 cooperatingwith proximal female threads 278 formed in lag screw head 272. Matingthreads 276, 278 are left handed threads. Lag screw head 272 includeschamber 280 to accommodate distal threaded end 276 of lag screw shaft274 when lag screw head 272 is operably positioned on lag screw shaft274. Lag screw head 272 includes distal lag screw threads 282 forimplanting lag screw 264 into femur 108 as described hereinabove.Cooperating threads 276, 278 are left handed threads, while lag screwthreads 282 are right handed threads. In this way, lag screw head 272may be threadedly engaged on lag screw shaft 274 and, rotation of lagscrew head 272 in a clockwise fashion to effect implantation of lagscrew threads 282 into femur 108 will not cause lag screw head 272 tobecome separated from lag screw shaft 274.

FIG. 91 illustrates an alternative embodiment lag screw 264′ in whichlag screw head 272 includes flange 277 and lag screw shaft 274 includesbearing protrusion 275. In this embodiment, bearing protrusion 275 ispositioned intermediate the most proximal portion of lag screw head 272′and flange 277. In this arrangement, flange 277 cooperates with the mostproximal portion of lag screw head 272 and bearing protrusion 275 toprohibit axial displacement of lag screw head 272′. Lag screw head 272′includes male hex 273′ operable for connection to flexible drive 281 asillustrated in FIG. 91. In use, flexible drive 281 will be insertedwithin tubular lag screw shaft 274 and engaged with male hex 273′ torotate lag screw head 272 to effect implantation thereof. In theembodiment illustrated in FIG. 42, lag screw shaft 274 is similarlycannulated to allow a flexible drive to enter lag screw shaft 274 andengage a cooperating protrusion (not shown) formed in lag screw head272. FIG. 92 illustrates an alternative embodiment of lag screw head272″ wherein male threads 276″ are formed on lag screw head 272″, andfemale threads 278′ are formed in lag screw shaft 274.

Alternative embodiments of guide plate 126 are illustrated in FIGS.50-55, and 65-68. Referring now to FIGS. 50-55, guide plate 126′includes screw apertures 286′ for use in securing guide plate 126 tofemur 108 as described hereinabove with respect to guide plate 126.Guide plate 126′ further includes spring pins 318 traversing axiallyoriented apertures in guide plate 126′. As illustrated in FIG. 55,spring pins 318 engage alternate ends of springs 316 to hold springs 316in position within guide plate 126′. As illustrated in FIG. 51, guideplate 126′ includes circular opening 322 as well as elliptical opening324, with springs 316 extending into circular opening 322. In oneexemplary embodiment, springs 316 are formed from titanium.

Referring now to FIGS. 65-68, guide plate 126″ includes axially orientedapertures accommodating spring pins 318″ in much the same way as guideplate 126′ illustrated in FIGS. 50-55. Spring pins 318″ are utilized tohold springs 316″ in position within guide plate 126″ as illustratedwith respect to guide plate 126′ in FIG. 55. Guide plate 126″ includescircular opening 322″ as well as elliptical opening 324″ similar to thecorresponding openings found in guide plate 126′. The distal end ofguide plate 126″ includes gripping teeth 404 formed therein.Additionally, guide plate 126″ includes fixation screw shoulder 406 asillustrated, e.g., in FIG. 67. Fixation screw shoulder 406 will befurther described hereinbelow.

In use, guide plate 126′ is inserted through incision 106 for affixationto femur 108 in the same manner as guide plate 126 describedhereinabove. Insertion member 124′ illustrated in FIGS. 83-86 isutilized to position guide plate 126′ through incision 106 for placementatop greater trochanter 110. In many respects, insertion instrument 124′is similar to insertion instrument 124 illustrated in FIGS. 19-22 andfurther described hereinabove. As illustrated in FIGS. 83-86, insertioninstrument 124′ includes elongate aperture 132′ for accommodatingstabilization nail 144 (FIG. 2). Insertion member 124′ includes releasemember 134′ connected via connecting rods 348, and cylindrical connector352 to release bars 350. Release bars 350 travel in axially orientedslots formed in the distal end of insertion member 124. The distal endof insertion member 124′ includes elliptical protrusion 354 forplacement within elliptical aperture 324 of guide plate 126′.Cooperation of elliptical protrusion 354 with elliptical aperture 324insures proper rotational alignment of insertion member 124′ and guideplate 126′. Upon achieving proper rotational alignment, insertion member124′ may be axially displaced into the central aperture of guide plate126′, with springs 316 engaging spring slots 326″ formed in opposingsides of the distal end of insertion member 124′. In this way, springs316 lock guide plate 126′ to insertion member 124′. Bevel 317facilitates positioning of springs 316 in spring slots 326″. After guideplate 126′ is secured to femur 108 as described hereinabove with respectto guide plate 126, release bars 350 are utilized to actuate springs 316radially outwardly from their normally biased position to disengagespring slots 326″ and allow for removal of insertion member 124′ fromguide plate 126′.

Release member 134′ is utilized to effect axial displacement of releasebars 350 from the position illustrated in FIG. 85 in which spring slots326″ are available for engagement with springs 316 to the positionillustrated in FIG. 84 in which release bars 350 provide a radiallyoutward force to springs 316 to allow for disengagement of insertionmember 124′ from locking engagement with guide plate 126′ and allow forremoval of insertion member 124′ through incision 106. As illustrated inFIG. 85, release bars 350 include a distal bevel to facilitate movementfrom the position illustrated in FIG. 85 to the position illustrated inFIG. 84 to effect release of springs 316 from spring slots 326″.Similarly, insertion member 124′ can be lockingly engaged with guideplate 126″ illustrated in FIGS. 65-68 to effect implantation of guideplate 126″ through incision 106 for placement atop greater trochanter110.

When utilizing guide plate 126″ illustrated in FIGS. 65-68, plungereamer 480 (FIG. 82) must first be utilized to form a cavity in femur108 extending through greater trochanter 110. Plunge reamer 480 includesreamer head 484 and flange 482. In this embodiment, plunge reamer 480 isinserted through incision 106 and reamer head 484 is placed atop greatertrochanter 110. As with initial placement of guide plate 126 and 126′, afluoroscope may be utilized to facilitate proper positioning of reamerhead 484 atop greater trochanter 110. Furthermore, a surgeon may rely ontactile feedback for proper positioning of plunge reamer 480. Plungereaming is effected until flange 482 abuts greater trochanter 110.Plunge reamer 480 is thereafter removed through incision 106 to allowfor placement of guide plate 126″ atop greater trochanter 110. Fixationscrew 394 illustrated in FIGS. 61-64 is thereafter utilized to secureguide plate 126″ to greater trochanter 110. While insertion instrument124′ may be utilized to initially position guide plate 126″ throughincision 108, it must be removed prior to implantation of fixation screw394.

As illustrated in FIGS. 61-64, fixation screw 394 includes fixationscrew head 398 with fingers 396 axially depending therefrom. Screwthreads 400 are formed on axially extending fingers 396. The proximalend of fixation screw 394 includes locking channel 402, the utility ofwhich will be further described hereinbelow. Fixation screw head 398forms a flange engagable with fixation screw shoulder 406 formed inguide plate 126″ (FIG. 67). Fixation screw 394 is inserted through thecentral aperture of guide plate 126″ and is screwed into the bore formedthrough greater trochanter 110 to secure guide plate 126″ atop greatertrochanter 110. Threads 400 cut into the femoral bone stock to providefixation of fixation screw 394.

Fixation screw placement instrument 470 as illustrated in FIGS. 80 and81 is utilized to insert fixation screw 394 through incision 106 and tosecure fixation screw 394 within guide plate 126″ as describedhereinabove. Referring now to FIGS. 80 and 81, fixation screw placementinstrument 470 includes a proximal handle as well as a distal end havingblades 466 and ball detent 464 formed therein. In use, blades 466 engagelocking channels 402 in fixation screw 394, with ball detent 464engaging a detent (not shown) formed in the inner diameter of lockingscrew 394. The proximal handle of fixation screw placement instrument470 may then be utilized to rotate fixation screw 394 and secure thesame within femur 108.

When utilizing either guide plate 126′ (FIGS. 50-55) or guide plate 126″(FIGS. 65-68), alternative embodiment guide tube/retractor 154′ isutilized in lieu of guide tube/retractor 154 described hereinabove withreference to guide plate 126. Guide tube/retractor 154′ is illustratedin FIGS. 56, 57, 59, and 60. As illustrated, guide tube/retractor 154′includes a distal end having rounded portion 330 with spring slots 326formed on opposing sides thereof. Furthermore, distal end of guidetube/retractor 154′ includes engagement protrusions 328 having a radiusof curvature matching the rounded ends of elliptical openings 324 and324″ in guide plates 126′ and 126″, respectively. Opposing spring slots326 formed in the distal end of guide tube/retractor 154′ are utilizedto selectively affix guide tube/retractor 154′ to either guide plate126′ or 126″ in the same fashion as described above with respect toinsertion member 124′. As illustrated in FIG. 58, angled guidetube/retractor 296′ is provided for use with guide plates 126′ or 126″.Angled guide tube/retractor 296′ provides the same functionality asangled guide tube/retractor 296 described hereinabove with respect toguide plate 126 and includes a distal end identical to the distal end ofstraight guide tube/retractor 154 illustrated in FIGS. 56, 57, 59, and60. Straight guide tube/retractor 154′ and angled guide tube/retractor296′ have a greater axial length than straight guide tube/retractor 154and angled guide tube/retractor 296 described in the primary embodimentof the present invention. The inventors of the present inventioncontemplate various guide tube/retractors having differing lengths toaccommodate physiological differences in a variety of patients as wellas different attaching mechanisms in accordance with the variousembodiment of the present invention. As illustrated in FIGS. 56-60,guide tube/retractors 154′ and 296′ include latch channels 332 and 332′,respectively. The utility of latch channels 332 and 332′ will be furtherdescribed hereinbelow.

Referring now to FIGS. 44 and 45, alignment device 156′ is utilized inconjunction with guide tube/retractors 154′, 296′ to select theappropriate guide tube/retractor as described hereinabove with respectto alignment device 156. Alignment device 156′ includes alignment guidetube 306 for positioning within guide tube/retractor 156′, or 296′ andproviding a stable base for alignment device 156′ as described abovewith respect to insertion portion 160 of alignment device 156 (FIGS. 29and 30). Alignment guide tube 306 includes latch 308 pivotally connectedthereto via pivot pin 314. Additionally, alignment guide tube 306includes distal flat 386 which, in this exemplary embodiment will bottomout on the shoulder formed between the elliptical aperture and a roundaperture in guide plates 126′ and 126″. Latch 308 includes oppositelydepending locking tabs 310 extending from opposing sides thereof. Latch308 is biased into the position illustrated in FIG. 45 by spring 312. Asalignment guide tube 306 is inserted into guide tube/retractor 156′ or296′, locking tabs 310 contact the proximal end of guide tube/retractor154′ or 296′. After achieving this position, the distal end of latch 308is depressed radially inwardly to move locking tabs 310 away fromalignment guide tube 306 and allow for further insertion of alignmentguide tube 306 into guide tube/retractor 154′ or 296′. As indicatedabove, distal flat 386 bottoms out on the shoulder formed between theelliptical and the round apertures in guide plates 126′ and 126″ whenalignment guide tube 306 is fully inserted into guide tube/retractor154′ or 296′. In this position, locking tabs 310 align with latchchannels 332 and latch 308 may be allowed to return to its normallybiased position as illustrated in FIG. 45. In this position, lockingtabs 310 engage latch channels 332 to prevent axial displacement ofalignment guide tube 306 relative to guide tube/retractor 154′ or 296′.Furthermore, when engaged in latch channels 332, locking tabs 310 resistrotational movement of alignment guide tube 306. In all other respects,alignment device 156′ is identical to alignment device 156 describedabove and is utilized in a similar fashion to choose between straightguide tube/retractor 154′ and angled guide tube/retractor 296′.

Reaming of femoral cavity 224 is effected with reamers having guidetubes and latches similar to guide tube 306 and latch 308 describedabove with respect to alignment device 156′. In one alternativeembodiment, combination reamer 358 illustrated in FIGS. 46-49 isutilized to effect both plunge, i.e., straight reaming into the femur aswell as swivel reaming. In this embodiment, combination reamer 358 isinserted into guide tube/retractor 154′ or 296′, with orientation plate384 cooperating with one of the longitudinal channels formed in guidetube/retractor 154′ or 296′ (see, e.g., FIGS. 56-60) to properly aligncombination reamer 358 within the guide tube/retractor. As illustratedin FIGS. 46-49, combination reamer 358 includes reamer head 360connected to the distal end of reamer shaft 362. Reamer shaft 362includes flange 364 positioned toward the distal end thereof and ratchetteeth 382 formed toward the proximal end thereof. As illustrated in FIG.49, reamer shaft 362 is positioned within reamer shaft tube 372 havingreamer depth lock 374 formed on a proximal end thereof. Reamer depthlock 374 includes ratchet release 376 connected via connecting rod 378to ratchet head 380 as illustrated in FIG. 49. As illustrated in FIG.49, a spring is utilized to bias ratchet head 380 into engagement withratchet teeth 382 on reamer shaft 362. Ratchet release 376 is pivotallyconnected to reamer depth lock 374 such that actuation of ratchetrelease 376 causes outward radial movement of ratchet head 380 withrespect to reamer shaft 362, thus disengaging the ratchet teeth formedin ratchet head 380 with ratchet teeth 382 and allowing for relativeaxial movement of reamer shaft tube 372 and reamer shaft 362. In theconfiguration illustrated in FIG. 49, combination reamer 358 can beutilized to effect plunge reaming, with the terminal reaming depth beingreached when the distal end of reamer shaft tube 362 contacts pivot 216.The overall depth of plunge reaming may thus be adjusted by varying theaxial displacement of reamer depth lock 374 along reamer shaft 362.

As illustrated in FIG. 46, combination reamer 358 includes combinationreamer guide tube 366 having channel 368 formed therein. Swivel/plungereaming selector 370 is operably connected to a proximal end ofcombination reamer guide tube 366. As illustrated in FIG. 49, rotationguide pin 388 is fixably secured to combination reamer guide tube 366and positioned within rotation guide channel 390 of swivel/plungereaming selector 370. Swivel/plunge reaming selector 370 may be rotatedabout guide tube 366 of combination reamer 358 between the extremesillustrated in FIGS. 47 and 48, i.e. with rotation guide pin 388 inopposite ends of rotation guide channel 390. When swivel/plunge reamingselector 370 is positioned as illustrated in FIG. 47, swivel reamingwith combination reamer 358 is not allowed because swivel/plunge reamingselector 370 covers channel 368. To allow for swivel reaming,swivel/plunge reaming selector 370 is rotated into the positionillustrated in FIG. 48. In the position illustrated in FIG. 48, channel392 in swivel/plunge reaming selector 370 aligns with channel 368 inguide tube 366 of combination reamer 358. In this position, swivelreaming can be effected as illustrated in FIG. 48. Reamer shaft 362 isconnected to guide tube 366 of combination reamer 358 via pivot 216′ andpivot pins 218′ to allow for the swivel reaming illustrated in FIG. 48.Combination reamer 358 includes distal flat 386′ for signaling completeinsertion of combination reamer 358 into reamer/guide tube 154′ or 296′.As described above with respect to alignment guide tube 306 of alignmentdevice 156′, distal flat 386′ bottoms out on the shoulder formed betweenthe elliptical and round apertures in guide plates 126′ and 126″ whencombination reamer 358 is fully inserted into guide tube/retractor 154′or 296′.

Upon completion of femoral reaming, guide tube/retractor 156′ or 296′ isremoved from locked engagement with guide plate 126′ or 126″ with springlock release instrument 336 illustrated in FIGS. 87-89. As illustratedin FIGS. 87-89, spring lock release instrument 336 includes a tubularbody sized for insertion into guide tube/retractor 156′ or 296′ with adistal shoulder indicating complete insertion of spring lock releaseinstrument 336 into guide tube/retractor 156′ or 296′ in the mannerdescribed above with respect to alignment guide tube 306 of alignmentdevice 156′, and combination reamer 358. Moreover, spring lock releaseinstrument 336 includes latch 308′ as described hereinabove with respectto guide tube 306 of alignment device 156′. After insertion of springlock release instrument 336 into guide tube/retractor 156′ or 296′,handle 338 is utilized to axially displace actuation rod 342 traversinginternal aperture 344 of spring lock release instrument 336 into theposition illustrated in FIG. 89. In this position, the distal ramped endof actuation rod 342 contacts the proximal ends of release pins 346 toovercome the biasing force of springs 347 (FIG. 88) and cause releasepins 346 to protrude from spring lock release instrument 336 asillustrated in FIG. 89. In this position, release pins 346 traverseapertures 155, 155′ and act against springs 316 to disengage springs 316from spring slots 326 and allow for removal of guide tube/retractor 154′or 296′. In the embodiment illustrated, release pins 346 are springbiased. The inventors of the current invention contemplate that releasepins 346 could be linked to actuation rod 346 via a mechanical linkagewhereby pulling actuation rod 342 would pull pins 346 into theinstrument and, conversely, pushing rod 342 would push the pinsoutwardly from the instrument. Moreover, while release pins 346 areillustrated as forming an acute angle with the longitudinal axis ofspring lock release instrument 336, release pins 346 could betransversely positioned within spring lock release instrument 336.

Guide tube/retractor 156″ in accordance with a further alternativeembodiment of the present invention is illustrated in FIGS. 69 and 70.In this embodiment, guide tube/retractor 154″ is configured foraffixation directly to greater trochanter 110, with guide plate 126 nolonger being used. As illustrated in FIGS. 69 and 70, guidetube/retractor 154″ includes gripping teeth 404″ formed in a distal endthereof. Gripping teeth 404″ are utilized to position guidetube/retractor 154″ atop greater trochanter 110 and fixation screw 394will be positioned within guide tube/retractor 154″ and utilized toaffix guide tube/retractor 154″ to femur 108 as described above withreference to guide plate 126″. While not illustrated in FIGS. 69 and 70,guide tube/retractor 154″ includes a shoulder for engaging screw head398 of fixation screw 394 to complete fixation of guide tube/retractor154″ to femur 108 in the same manner as described above with respect toguide plate 126″.

In an alternative embodiment of the present invention, flexible reamer428 illustrated in FIGS. 75 and 76 is utilized in lieu of the curvedreamers described above to ream into femoral head 114 and into the shaftof femur 108. As illustrated in FIGS. 75 and 76, flexible reamer 428includes reaming head 432 and flexible reaming shaft 434. As illustratedin FIG. 76, flexible reaming shaft 434 is cannulated, allowing forinsertion of flexible reamer shaft 434 over a guide wire to guidereaming into femoral head 114 and into the shaft of the femur 108.Flexible reamer 428 illustrated in FIGS. 75 and 76 utilizes flexiblereamer guide tube 430 and a latch member associated with a particularreamer/guide tube of the present invention. However, flexible reamer 428may include various guide tubes having physical characteristics allowingfor use of flexible reamer 428 with the various guide tube/retractors ofthe present invention. As illustrated in FIGS. 75 and 76, the proximalend of flexible reamer shaft 434 is connected to flange 436 which actsagainst the proximal end of flexible reamer guide tube 430 to limit thereaming depth of flexible reamer 428.

In one exemplary embodiment, flexible reamer guide 408 (FIGS. 71 and 72)is utilized to position guide wire 410 within the femur to guideflexible reamer 428. As illustrated in FIGS. 71 and 72, flexible reamerguide 408 includes guide 416 having guide shaft fixation channel 412formed therein. Guide 416 is insertable within guide channel 420 of themain body of flexible reamer guide 408 as illustrated in FIG. 72. Guidepegs 418 depend from guide 416 and are further inserted within guidechannel 420 as illustrated in FIG. 72. Flexible reamer guide tube 486 offlexible reamer guide 408 includes advance/retract screw aperture 488and guide wire aperture 490. With guide 416 inserted in guide channel420 of flexible reamer guide tube 486, guide wire 410 is inserted inguide wire aperture 490 and positioned within guide shaft fixationchannel 412. Set screw 414 is utilized to secure guide wire 410 withinguide shaft fixation channel 412. Advance/retract screw 422 traverses aproximal aperture in guide 416 and advance/retract screw aperture 488,and is threadably engaged with receiving block 426 as illustrated inFIG. 72. Advance/retract screw 422 includes flange 424 for abutting theproximal end of guide 416 and for forcing guide 416 to be distallydisplaced in flexible reamer guide tube 486 in response to distalmovement of advance/retract screw 422. Guide wire 410 is formed from amemory metal such as, e.g., NITINOL. With this in mind, the advanceretract screw 422 may be retreated from receiving block 426 to allowguide wire 410 to retreat into guide wire aperture 490 to completelyretract guide wire 410 within flexible reamer guide tube 486 of flexiblereamer guide 408, without losing the ability of guide wire 410 to regainthe bent shape illustrated in FIG. 71.

In use, flexible reamer guide 408 is inserted within a guidetube/retractor of the present invention with guide wire 410 notprotruding from the distal end of guide wire aperture 490. The proximalend of advance retract screw 422 is thereafter actuated to force guide416 and, consequently, guide wire 410 through flexible reamer guide tube486 and into femoral head 414 as illustrated in FIG. 73. Once guide wire410 achieves the position illustrated in FIG. 73, set screw 414 may beremoved and flexible reamer guide 408 removed from the guidetube/retractor, leaving guide wire 410 in place within femur 108.Flexible reamer 428 may then be operably inserted in guidetube/retractor 154 as illustrated in FIG. 74 and, with guide wire 410positioned within the cannula of flexible reamer 428, femoral cavity 224may be extended into femoral head 114 as illustrated in FIG. 74, withflexible reamer 428 being guided by guide wire 410. A similar techniquemay be utilized for advancing guide wire 410 into the femoral shaft toextend femoral cavity 224 therein.

In a further alternative embodiment, flexible reamer guide wire bender440 as illustrated in FIGS. 77-79 is utilized to in vivo bend a guidewire to guide reaming into, e.g., femoral head 114 as illustrated, e.g.,in FIG. 73. As illustrated in FIGS. 77-79, flexible reamer guide wirebender 440 includes guide tube 456 for insertion into a guidetube/retractor of the present invention. Guide tube 456 includes a pairof elongate apertures. A first of these apertures accommodates innerwire tube 450 and outer wire tube 452 as illustrated, e.g., in FIG. 79.The second of the elongate apertures formed in guide tube 456accommodates adjustment screw 458 as illustrated, e.g., in FIG. 79. Wireshaping head 448 is pivotally connected via pivot pin 444 to the distalend of flexible reamer guide wire bender 440 as illustrated in FIGS. 78and 79. As illustrated in FIGS. 77 and 79, roller 442 is positionedabout pivot pin 444. Wire shaping head 448 further includes roller pin446 for connecting a second roller 442 in a rotatable manner to wireshaping head 448. As illustrated in FIG. 77, screws 454 are utilized toaffix the distal end of flexible reamer guide wire bender 440 to guidetube 456. As illustrated in FIG. 79, outer wire tube 452 includesproximal wire extreme 462 against which an end of a guide wire willabut. Outer wire tube 452 is threadably engagable with either guide tube456 or inner wire tube 450 so that outer wire tube 452 may be advancedinto guide tube 456 to force a guide wire positioned against proximalwire extreme 462 through distal aperture 500 of flexible reamer guidewire bender 440. Adjustment screw 458 is utilized to rotate wire shapinghead 448 about pivot pin 444 whereby rollers 442 bend a guide wire intothe desired shape as it exits distal aperture 500. Shaping of a guidewire in vivo with flexible reamer guide wire bender 440 may be observedwith a fluoroscope.

A guide wire bent with flexible reamer guide wire bender 440 will beadvanced into, e.g., femoral head 114 as illustrated, e.g., in FIG. 73with respect to guide wire 410. In this way, a flexible reamer will beutilized to extend femoral cavity 224 toward the femoral head asillustrated in FIG. 74. A similar procedure may be utilized forextending femoral cavity 224 into the shaft of femoral 108.

While this invention has been described as having exemplary designs, thepresent invention may be further modified with the spirit and scope ofthis disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention utilizing its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains.

1. A prosthetic implant, comprising: a bag; a fill access providingaccess to an interior of said bag; and a tube, said bag secured to anexterior of said tube.
 2. The prosthetic implant of claim 1, furthercomprising: a lag screw, comprising: a shaft, said shaft having anexterior geometry cooperating with an interior geometry of said tube toallow relative axial displacement of said lag screw and said tube; and ascrew head, said screw head rotabably connected to said shaft.
 3. Theprosthetic implant of claim 2, wherein said lag screw shaft includes aninterior elongate aperture, and wherein said screw head includes a driveconnector for selective engagement with a rotatable drive instrument,said interior elongate aperture of said lag screw shaft providing accessto said drive connector.
 4. The prosthetic implant of claim 2, whereinsaid lag screw shaft is curved from a proximal end thereof to a distalend thereof, and wherein said tube is curved from a proximal end thereofto a distal end thereof, said tube and said lag screw shaft having asimilar curvature, whereby said lag screw shaft is slidable relative tosaid tube when said lag screw shaft is placed within said tube.
 5. Theprosthetic implant of claim 1, further comprising a fill tube, said filltube providing said access.
 6. The prosthetic implant of claim 5,wherein said fill tube has a length, said length sized to allowretrograde filling of said bag.
 7. The prosthetic implant of claim 1,further comprising: a substantially V-shaped expansion bar positionedwithin said bag.
 8. A guide plate for guiding a plurality of instrumentsutilized to reduce a bone fracture, comprising: a guide plate bodyhaving a central aperture through which said instruments can pass, saidguide plate including means for selectively locking an instrument guidethereto; and a means for affixing said guide plate to the bone.
 9. Theguide plate of claim 8, wherein said means for affixing said guide plateto the bone comprises a plurality of screws cooperating with a pluralityof screw apertures in said guide plate.
 10. The guide plate of claim 8,wherein said means for affixing said guide plate to the bone comprises acannulated fixation screw including a fixation screw head with aplurality of resilient fingers depending therefrom, said resilientfingers having threads thereon, said fixation screw abutting a shoulderof said guide plate when said resilient fingers are positioned throughsaid central aperture.
 11. A straight reamer, comprising: a straightreamer guide tube having an elongate aperture formed therein; and astraight reamer shaft located in said elongate aperture of said straightreamer guide tube, said reamer shaft including a straight reamer head ona distal end thereof, said straight reamer shaft further including aflange, said straight reamer guide tube positioned intermediate saidflange and said straight reamer head.
 12. A swivel reamer, comprising: aswivel reamer guide tube having a pivot pivotally connected thereto,said pivot having a longitudinal aperture; a swivel reamer shaft locatedin said longitudinal aperture of said pivot, said swivel reamer shafthaving a pair of flanges abutting opposing ends of said pivot; and aswivel reamer head formed on a distal end of said swivel reamer shaft,said swivel reamer head protruding from said swivel reamer guide tube;said swivel reamer guide tube including a cutout, whereby said swivelreamer shaft traverses said cutout when said pivot pivots relative tosaid swivel reamer guide tube.
 13. A curved reamer, comprising: a curvedreamer guide tube including a curved guide channel; and a curved reamershaft positioned in said curved guide channel, whereby said curvedreamer shaft can be advanced through said curved reamer guide channel,said curved reamer shaft including a reamer head on a distal endthereof.
 14. An angled guide tube/retractor, comprising: a tubulardistal end including a means for selectively affixing the guidetube/retractor to a guide plate; and a tubular retractor body, saiddistal end having a distal end longitudinal axis, said retractor bodyhaving a retractor body longitudinal axis, said distal end longitudinalaxis forming an acute angle with said retractor body longitudinal axis.15. The angled guide tube/retractor of claim 14, wherein said acuteangle measures 10 degrees.
 16. An alignment device for choosing a guidetube/retractor through which a medical procedure will be performed,comprising: an insertion member having an exterior geometry cooperatingwith a hollow interior of the guide tube/retractor to allow insertion ofsaid insertion member into the guide tube/retractor, whereby saidinsertion member is substantially prohibited from rotating about an axisperpendicular to a longitudinal axis thereof when said insertion memberis inserted in the guide tube/retractor; a transverse bar connected tosaid insertion member; and an alignment arm slidably attached to saidtransverse bar, said alignment arm having a distal end, said distal endhaving a shape substantially matching a biological landmark, said distalend aligning with said biological landmark when the appropriate guidetube/retractor is utilized.
 17. A combination reamer, comprising: acombination reamer guide tube having a pivot pivotally connectedthereto, said pivot having a longitudinal aperture; a combination reamershaft located in said longitudinal aperture of said pivot; a combinationreamer head formed on a distal end of said combination reamer shaft,said combination reamer head protruding from said combination reamerguide tube; said combination reamer guide tube including a cutout,whereby said combination reamer shaft traverses said cutout when saidpivot pivots relative to said swivel reamer guide tube; a reamer shafttube slidably connected about said combination reamer shaft, said pivotpositioned on said combination reamer shaft intermediate a distal flangeof said combination reamer shaft and a distal end of said reamer shafttube; a lock mechanism for selectively locking said reamer shaft tube tosaid combination reamer shaft; and a swivel/plunge reaming selectorrotatably connected to said combination reamer guide tube, saidswivel/plunge reaming selector having a selector cutout, saidswivel/plunge reaming selector being rotatable relative to saidcombination reamer guide tube to a first position in which said selectorcutout is aligned with said combination reamer guide tube cutout toallow for rotation of said pivot to effect swivel reaming, saidswivel/plunge reaming selector being further rotatable relative to saidcombination reamer guide tube to a second position in which saidselector cutout is not aligned with said combination reamer guide tubecutout to prevent rotation of said pivot and thereby prevent swivelreaming.
 18. A flexible reamer guide, comprising: a flexible reamerguide tube including a substantially straight elongate guide wireaperture; and a guide wire positioned in said guide wire aperture, saidguide wire including a distal end having a curvature, said guide wireformed from a shape memory substance, whereby said guide wire willretain said curvature after being deflected, whereby said guide wire isdeflected when the distal end is positioned in said guide wire aperture.19. The flexible reamer guide of claim 18, wherein said flexible reamerguide tube further includes an elongate guide channel, said flexiblereamer guide further comprising: a guide position in said guide channel,said guide wire secured to said guide, whereby said guide controls theposition of said guide wire in said guide wire aperture, and wherebyrelative axial displacement of said guide relative to said flexiblereamer guide tube causes relative axial displacement of said guide wirerelative to said flexible reamer guide tube.
 20. The flexible reamerguide of claim 19, wherein said flexible reamer guide tube furtherincludes an elongate advance/retract screw aperture, said flexiblereamer guide further comprising: an advance/retract screw positioned insaid advance/retract screw aperture, said advance/retract screwincluding an advance/retract screw flange, said guide including aproximal flange, said advance/retract screw threadably connected to saidflexible reamer guide tube, whereby rotation of said advance/retractscrew in a first direction causes said advance/retract screw to beaxially displaced relative to said flexible reamer guide tube andfurther causes engagement of said advance/retract screw flange with saidproximal flange of said guide to thereby effect axial displacement ofsaid guide and said guide wire relative to said flexible reamer guidetube.
 21. A flexible reamer guide wire bender, comprising: a flexiblereamer guide wire bender guide tube including an elongate guide wireaperture; a guide wire positioned in said guide wire aperture; a meansfor shaping said guide wire connected to a distal end of said flexiblereamer guide wire bender guide tube; and a means for advancing saidguide wire through said means for shaping to thereby shape said guidewire.
 22. The flexible reamer guide wire bender of claim 21, whereinsaid means for shaping said guide wire comprises: a wire shaping headpivotally connected to said flexible reamer guide wire bender guidetube; a pair of rollers rotatably connected to said wire shaping head;and an adjustment screw threadably engaged with said flexible reamerguide wire bender guide tube, said adjustment screw having a distal endfor contacting said wire shaping head and rotating said wire shapinghead relative to said flexible reamer guide wire bender guide tube,whereby said guide wire contacts said rollers and is thereby shaped assaid means for advancing advances said guide wire therethrough.
 23. Aflexible reamer guide wire bender, comprising: a flexible reamer guidewire bender guide tube including an elongate guide wire aperture; aguide wire positioned in said guide wire aperture; a wire shaping headpivotally connected to a distal end of said flexible reamer guide wirebender guide tube; a pair of rollers rotatably connected to said wireshaping head; and an adjustment screw threadably engaged with saidflexible reamer guide wire bender guide tube, said adjustment screwhaving a distal end for contacting said wire shaping head and rotatingsaid wire shaping head relative to said flexible reamer guide wirebender guide tube, said guide wire contacting said rollers as said guidewire exits said distal end of said flexible reamer guide wire benderguide tube.
 24. The flexible reamer guide wire bender of claim 23,further comprising: a means for advancing said guide wire through saidwire shaping head.